The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in ...

Opportunities lie in mastering FDA procedures for INDs, NDAs, and ANDAs in the largest pharma market, enhancing compliance, understanding regulatory strategies, and improving FDA communications.

Pharmaceutical industry officials speaking at a Wednesday workshop on complex generics suggested that the US Food and Drug Administration (FDA) create alternative pathways for assessing bioequivalence ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Generic drug repurposing is an underused but promising tool for finding new, affordable therapies. Creating a pull incentive can spur developers to finally explore the untapped potential in these ...

India got it earlier this year, and Canada approved it last month. But when is the United States going to get a generic ...

Generic drugs are cheaper copies of brand drugs, offering significant savings to patients. Once a brand-name drug's patent expires, competitors can apply to make generic versions. Generic ...

Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...